CUPCAKE - ethyl alcohol liquid 
Huijing (Shanghai) Bio-tech Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Inactive Ingredients

carbomer 940, PEG-12

dimethicone, red-33, tocopheryl

acetate, triethanomaline,

water

Active Ingredient

Ethyl Alcohol, 65 % v/v

Purpose  Antimicrobial

Uses

hand sanitizer to help

reduce bacteria on skin

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

Put a dime sized drop onto hands

and rub together briskly until dry.

Other information

Store below 110 F (43 C)

Warning

For external use only

Flammable, keep away from fire or flame.

image description

CUPCAKE  
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71537-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71537-002-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2017
Labeler - Huijing (Shanghai) Bio-tech Co., Ltd (544482337)
Establishment
NameAddressID/FEIBusiness Operations
Huijing (Shanghai) Bio-tech Co., Ltd544482337manufacture(71537-002)

Revised: 6/2017
Document Id: 853d3db2-b928-4915-a6a3-5f2363e11e24
Set id: baaaa8da-a1b6-47af-92ff-a52e9a80bf64
Version: 1
Effective Time: 20170623
 
Huijing (Shanghai) Bio-tech Co., Ltd